This invention relates generally to methods of performing non-invasive medical procedures on a living being, and more particularly to a method for expeditiously destroying tissue, such as a gall bladder, located within a living being by circulating a sclerosing agent therein/thereabout. In addition, the method may also comprise the step of introducing a symphysis agent before, simultaneously or after the introduction of the sclerosing agent.
Medical instruments, such as catheters having working heads located at the free end thereof, are widely accepted in the medical community for effecting various procedures within a patient which had previously been accomplished by general surgery. Those instruments have thus opened the way for what has become known as "non-invasive" surgery. The destruction of stones, e.g., gallstones, kidney stones, etc. is one area in which non-invasive procedures are undergoing significant evolution, and several patents and patent applications are directed thereto.
For example, in U.S. Pat. No. 4,679,558 (Nash et al.), assigned to the same assignee of this invention there is disclosed and claimed an instrument for effecting the destruction of a stone or other hard body located within the body of a living being. That instrument basically comprises a catheter having a working head located at its distal end. The working head is arranged to engage the stone to mechanically destroy, e.g., pulverize, it.
In U.S. Pat. No. 4,811,735 (Nash et al.), also assigned to the same assignee of this invention and whose disclosure is incorporated by reference herein there is disclosed and claimed an improved catheter and method of use for disintegrating or otherwise destroying a stone, such as a gallstone, within the body of a living being. That catheter basically comprises a small diameter instrument with a working head located at the distal end thereof. The catheter is capable of being located at any position within the patient's body so that the working head is located adjacent the stone to be destroyed. The working head comprises a bladed member having at least one impacting surface thereon. In accordance with one aspect of that invention, the bladed member is arranged to be moved from a retracted position, wherein its impacting surface is located adjacent the periphery of the catheter, to an extended position, wherein the impacting surface extends substantially beyond the periphery of the catheter. The working head is arranged to be rotated at a high speed about the longitudinal axis of the catheter when the impacting surface is extended. Thus, the impacting surface repeatedly impacts the stone to disintegrate or otherwise destroy it. The rotation of the working head serves to create a vortex flow in the liquid which is located at the situs of the stone. This vortex flow tends to pull the stone into the rotating impacting surface(s) to expedite the destruction of the stone. A shroud is provided about the distal end of the catheter to aid in directing the stone to the rotating blade while also protecting adjacent body tissue from being engaged by the rotating blade.
In U.S. patent application Ser. No. 07/322,754 filed on Mar. 13, 1989, entitled Stone Pulverizing Apparatus With Improved Working Head And Method Of Use, which is assigned to the same assignee as this invention and whose disclosure is incorporated by reference herein, there is disclosed yet a further improvement in a stone destroying instrument, e.g., catheter, and its method of use. In accordance with on aspect of that invention the catheter utilizes a working head comprising at least two radially extending, blade-like members. Each blade-like member includes plural force-concentrating impacting surfaces and interposed grooves. The working head is arranged to be rotated at a high speed about the longitudinal axis of the catheter so that the impacting surfaces repeatedly engage the stone. The rotation of the working head produces a flow of the liquid in which the stone is located past the working head, with some portion of the liquid flowing through the plural grooves. The fluid flowing through the grooves reduces any boundary layer effect which would tend to sweep smaller particles away from the impacting surfaces. Accordingly, the efficient pulverization of the particles and the destruction of the stone is effected without appreciable injury to the body of the being.
In U.S. application Ser. No. 07/395,248 filed on Aug. 17, 1989, assigned to the same assignee as the present invention, is disclosed a method of mechanically destroying stones in a living being using vortex flow in a viscous fluid. The viscous liquid containing the stones helps to carry the stones into a position where they can be readily pulverized or otherwise destroyed and also tends to increase the vortex flow created by rotation of the working head of the stone destroying instrument.
All of these instruments disclosed in the aforementioned patents and patent applications are introduced into the portion of the patient's body, e.g., the gall bladder, where the stone(s) to be destroyed is (are) located. Saline solution is typically introduced into that body portion, and as the stone destruction process is carried out, i.e., as the stones are pulverized, the saline solution and stone particles produced by the process are extracted and fresh saline introduced.
After the destruction of the stones has been accomplished it is oftentimes necessary and/or desirable to also destroy or otherwise remove the gall bladder itself to prevent the reoccurrence of stones. Moreover, in some instances the removal of the gall bladder, without first removing or destroying any stones which may exist, is desirable. While this can be accomplished by general surgical procedures, it is desirable to be able to destroy the gall bladder by less intrusive procedures.
To that end in U.S. patent application Ser. No. 07/380,930, filed on Jul. 14, 1989, entitled Apparatus and Method For Sclerosis of Body Tissue, which is assigned to the same assignee as this invention, there is disclosed and claimed a an instrument for mechanically sclerosing the inner surface of the gall bladder so that the gall bladder undergoes necrosis and is ultimately absorbed by the patient's body.
The instrument disclosed and claimed in that application basically comprises a small diameter, elongated, flexible catheter having a longitudinal central axis and a movable working head located at the distal end thereof. The working head comprises a flexible member having a free end portion arranged to be extended generally outward radially from a retracted radial position with respect thereto when the apparatus is located within a body organ, and means for rotating the working head at a high rate of speed whereupon the free end portion engages tissue forming the organ's inner surface to mechanically denude the tissue.
In addition, to the foregoing prior art, the medical literature discloses the use of liquids to sclerose or ablate certain body portions or tissues of the body. One such use not involving gall bladders includes the intrapleural administration of bleomycin to serve as an effective sclerosing agent. R. D. Siegel, et al., Systemic Toxicity Following Intracavitary Administration of Bleomycin, Chest 1990 Aug.; 98(2):507. However, this study also concludes that this treatment may cause complications and/or serious side effects with patients having renal dysfunction.
Sclerotherapy using tetracycline has also been utilized in the treatment of hydroceles and epididymal cysts apparently with short term effectiveness and a long term cure rate of 77%. M. Honnens de Lichtenberg, et al., Tetracycline Sclerotherapy Of Hydroceles and Epididymal Cysts, Acta. Chir. Scand. 1990 Jun.-Jul.; 156(6-7); 439-40. Sclerotherapy is also reported to be suitable for outpatient therapy for the treatment of hydroceles utilizing a 3% sodium tetradecyl sulfate and 3.5% rolitetracycline solution. R. K. Rencken, et al., Sclerotherapy for hydroceles, J. Urol. 1990 May; 143(5):940-3.
Sclerotherapy has also been utilized in the prophylactic administration of antibiotics such as intravenous ampicillin in the sclerotherapy of esophageal varices. R. Pulanic, et al., Controlled Trial of the Prophylactic Administration of Antibiotics in Sclerotherapy of Esophageal Varices, J. Chemother. 1989 Aug.; 1(4);261-5.
While scientists have investigated various types of solutions in sclerotherapy, tetracycline has been widely experimented with since it is easy to administer, is readily available at a relatively low cost and has a low morbidity rate. In this regard, medical personnel have attempted to utilize tetracycline in the sclerotherapeutic treatment of various cancers. A. Contegiacomo, et al., The Treatment of Metastatic Pleural Effusion in Breast Cancer, Tumori 1987 Dec. 81;73(6);611-6; A. W. Lees, W. Hoy, Management of Pleural Effusions in Breast Cancer, Chest 1979 Jan.;75(1):51-3; T. C. Bayly, et al., Tetracycline and Quinacrine in the Control of Malignant Pleural Effusions, Cancer 1978 Mar.;41(3):1188-92.
Although the use of sclerosing agents has been widely experimented with, the rate of success in producing tissue symphysis is quite variable depending upon such factors as solution pH, etc. S. A. Sahn, et al., The pH of Sclerosing Agents: A Determinant of Pleural Symphysis, Chest 1979 Aug.;76(2):198-200.
It has been suggested by Dr. Christoph D. Becker, et al., Department of Radiology, University of Bern, Inselspital, Bern, Switzerland, Radiology April 1989; 171:235-240, to effect the destruction of the gall bladder in pigs by electrocoagulation of the cystic duct, followed by the introduction of ethanol and sodium tetradecyl-sulfate, to chemically sclerose the gall bladder inner surface whereupon the gall bladder eventually undergoes necrosis and absorption. This procedure however, has been criticized for use in humans, as being non-compatible with and/or ineffective for the human system. Dr. Robert C. Hall, Radiology Nov. 1989; 578-580. Dr. Becker has also utilized the procedure on humans with mixed results, including problems associated with mucosal regeneration. Dr. Christoph D. Becker, et al., Radiology Sep. 1990; 687-690.
While the use of alcohol as a sclerosing agent for the gall bladder may be generally sufficient to ultimately effect its destruction, it appears to leave something to be desired from the standpoint of efficiency and/or speed and/or effectiveness of the sclerosing action.
A need thus exists for a method for destroying tissue such as a gall bladder, utilizing a sclerosing agent and/or a symphysis agent which permits the body to absorb the destroyed gall bladder after treatment thereof.